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Circulating Tumour DNA (ctDNA) in Patients With Colorectal Cancer and the Relationship to Imaging Features of Extramural Venous Invasion

Sponsor: Imperial College London

NCT ID: NCT02579278

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Health checks and monitoring — no treatment given
Type of study
Observational (no treatment given)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Blood sample (mrEMVI positive patient) (other), Blood sample (mrEMVI negative patient) (other)
How long the study runs
Study runs about 169 months (dates as stated)
About the drug or intervention
Blood sample (mrEMVI positive patient) — other: Two blood samples are taken from each patient with mrEMVI positive tumours post chemoradiotherapy.
Patient visit burden
Not specified by the sponsor

In plain English

This study looks at small pieces of DNA (genetic material) from cancer cells that can be found in the blood, called circulating tumour DNA (ctDNA). Researchers want to find out whether these DNA pieces are linked to signs on scans of cancer growing into large veins near the bowel, known as extramural venous invasion (EMVI). The study is for people with bowel (colorectal) cancer and is run by Imperial College London.

Who can take part

  • You have bowel cancer confirmed by a tissue sample (biopsy), of a type called adenocarcinoma
  • You are able to have surgery that aims to cure the cancer
  • A CT (computed tomography) scan shows the cancer has not spread to other parts of the body
  • You had your pre-surgery staging scan within six weeks before your surgery
  • You have given written informed consent to take part
  • You are aged 16 or over

Who may not be able to

  • The cancer has spread to other parts of the body, including spread to the liver that could be removed with surgery
  • You have been diagnosed with another cancer at the same time
  • You cannot have the type of scan used to check for EMVI, because there is a medical reason the scan is not suitable for you

What taking part involves

  • • Not stated — ask the trial team

Time commitment: Not stated — ask the trial team

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Observing health over time
Ages
16 Years and over
Who
All
Number of participants
100
Started
2015-11
Last checked
2024-10

Plain English Summary

What is this study?

  • • Testing a new treatment for cancer
  • • Clinical study - 100 participants
  • • This study does not involve randomization or treatment

Who can take part?

  • • Ages 16 Years and over
  • • Diagnosed with cancer

Where?

  • • Margate - Queen Elizabeth the Queen Mother Hospital
  • • Hammersmith - St Mary's Hospital (Imperial)
  • • Sutton - Royal Marsden Hospital NHS Foundation Trust

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

This study does not involve randomization or treatment. Eligible patients have colorectal adenocarcinoma with no metastases eligible for curative surgery. A pre operative staging scan must have been completed within 6 weeks prior to surgery. Two x 20ml blood samples will be taken from each patient, one prior to and one during or within 24hrs after surgery. Patients are annually followed up to 3 years.

More detail

A multicentre observational study, ctDNA aims to provide the evidence base for metatstatic disease being caused by vascular methods of spread by determining if there is a link between EMVI status and ctDNA

CancerRectal Cancer

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 16 Years and over
  • Who can join: All genders

What the study is looking for

  • ✓Have a biopsy-confirmed colorectal adenocarcinoma
  • ✓Is eligible for curative surgery
  • ✓Has no that has spread disease on CT scan
  • ✓Has completed pre-operative staging scan within six weeks prior to surgery
  • ✓Have provided written agreement to take part to participate in the study

Who cannot take part

  • ✗Have that has spread disease (including resectable liver metastases)
  • ✗Have a synchronous second cancer
  • ✗Are not safe to use for any imaging able to determine EMVI status
See the full criteria
Inclusion Criteria: 1. Have a biopsy-confirmed colorectal adenocarcinoma 2. Is eligible for curative surgery 3. Has no metastatic disease on CT scan 4. Has completed pre-operative staging scan within six weeks prior to surgery 5. Have provided written informed consent to participate in the study 6. Be aged 16 years or over Exclusion Criteria: 1. Have metastatic disease (including resectable liver metastases) 2. Have a synchronous second malignancy 3. Are contraindicated for any imaging able to determine EMVI status

Where Is This Study? (3 UK sites)

Queen Elizabeth the Queen Mother Hospital

Margate CT9 4AN, United Kingdom

Recruiting
Site contact (verified)
Jess EvansPrincipal Investigator

St Mary's Hospital (Imperial)

Hammersmith W2 1NY, United Kingdom

Recruiting
Site contact (verified)
James KinrossPrincipal Investigator

Royal Marsden Hospital NHS Foundation Trust

Sutton SM2 5PT, United Kingdom

Recruiting
Site contact (verified)
Christos Kontovounisios, MDPrincipal Investigator

How to Get in Touch

Caroline Martin

Sponsor contact

CONTACT

+44 (0) 7749 655 817 c.martin1@imperial.ac.uk

Syvella Ellis

Sponsor contact

CONTACT

+44 (0) 7732 315 234 giclinicaltrials@imperial.ac.uk
Data sourced from ClinicalTrials.gov · Last verified: 2024-10